|Publication number||US5221263 A|
|Application number||US 07/922,315|
|Publication date||Jun 22, 1993|
|Filing date||Jul 30, 1992|
|Priority date||Jul 30, 1992|
|Also published as||CA2141295A1, CA2141295C, DE69323084D1, DE69323084T2, EP0652782A1, EP0652782A4, EP0652782B1, WO1994003221A1|
|Publication number||07922315, 922315, US 5221263 A, US 5221263A, US-A-5221263, US5221263 A, US5221263A|
|Inventors||George E. Sinko, Charles A. Jones|
|Original Assignee||Gesco International, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (9), Referenced by (81), Classifications (6), Legal Events (4)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This invention relates to an apparatus for inserting a small diameter catheters an extended distance into small human veins, and particularly an emplacement apparatus that may be axially split for removal from the catheter after the catheter is properly positioned in the vein.
As shown in U.S. Pat. No. 4,306,562 to Osborne, it is desirable to provide a catheter emplacement or introduction apparatus which will permit the catheter to be moved an extended distance through a vein of the patient to a location adjacent a particular organ. Such insertion must be accomplished without danger of rupturing the vein, other than by piercing the vein by a percutaneous needle. The catheter emplacement device preferably includes a elongated tubular sheath or introducer which is mounted over the needle and moveable axially relative to the needle after vein penetration has been accomplished to position the distal end of the sheath within the desired vein. The needle may then be withdrawn and the distal end of the catheter inserted through the sheath and into the vein and moved the desired distance through the vein to a desired location.
At this point, it is very desirable to effect the removal of the sheath from the body to minimize the possibility of infection or other adverse reaction of the body tissue to the presence of the sheath. A small diameter catheter may, however, remain in place in the vein for an extended period. To remove the catheter guide or sheath, the aforementioned Osborne patent proposes that the sheath be made of longitudinally molecularly oriented material and provides slits in the proximal ends of the sheath which permit the proximal ends to be grasped and a severing force applied to the axially severable material of the sheath. A similar technique has been employed for the insertion of pacemaker electrodes. See U.S. Pat. No. 4,166,469 to Littleford.
Such prior art devices have, however, two disadvantages, particularly when a very small diameter catheter must be employed, such as would be used in the veins of neonatal patients. It is understood that small diameter catheters generally have an external diameter of less than 0.1 inches. To introduce this small end of a very flexible element into the equally small bore of the catheter guide or sheath requires a fair amount of manual dexterity on the part of the medical technician to insert the catheter, particularly with blood flowing out the bore. Additionally, there is a problem that once the catheter is inserted, the removal of the catheter sheath through the application of opposing radial forces thereto very often results in a displacement of the catheter from its original position due to substantial force being required to effect the axial severance of the entire apparatus. It is therefore readily apparent that improvements in emplacement apparatus for catheters, and particularly for inserting small diameter catheters into small diameter veins, are needed.
A catheter emplacement apparatus embodying this invention comprises an elongated tubular sheath formed of flexible plastic material. Such sheath is provided with a pair of diametrically opposed, axially extending score lines extending the full length of the sheath. The sheath is mounted in surrounding relationship to a percutaneous needle, with only the sharpened tip end of the needle projecting from the sheath. Thus, the penetration of the patient's skin and selected vein by the needle will permit the distal end of the sheath to be moved forwardly over the needle and into the penetrated vein.
The proximal end of the sheath is bonded to a plastic operating element which has a central hub portion defining a central aperture in which the proximal end of the sheath is rigidly bonded. The proximal end of the aperture in the hub portion is provided with a conical configuration which functions as a convenient guide for insertion of a catheter into the sheath after removal of the needle. A pair of longitudinal slots are formed in the hub portion in overlying relation respectively to the score lines in the sheath.
A pair of diametrically opposed, manually graspable radial projections or wings are integrally formed on the proximal end of the hub portion and are located intermediate the two score lines provided in the sheath. Moreover, the wall portion of the hub portion connected to the intermediate radial projections are formed as thin walled conical segments, with external surfaces generally parallel to the enlarged conical opening provided for insertion of the catheter. This results in two thin walled conical segments being the only material preventing axial separation of the hub, longitudinally aligned with the score lines in the sheath, and each of these conical segments is provided with a score line aligned with the adjacent sheath score line.
After withdrawal of the needle from the selected vein and insertion of the catheter through the tubular sheath to a desired location within the selected vein, the introducer sheath element is moved rearwardly relative to the inserted catheter. Opposed radial severing forces are then manually applied to the two radial projections provided on the operating element. This force operates to readily severe the scored thin walled conical segment portions of the hub along their score lines, and, since these scores are respectively aligned with the two scores in the sheath portion, the sheath is readily separated, thus permitting the entire emplacement apparatus to be removed from the catheter in two pieces without disturbing the position of the distal end of the catheter in the selected vein.
The advantages of this arrangement in reducing the effort involved in inserting the catheter through the emplacement apparatus and in removing the emplacement apparatus will be readily apparent to those skilled in the art. Further advantages of the invention will be readily apparent for those skilled in the art from the following detailed description, taken in conjunction with the annexed sheets of drawings, on which is shown a preferred embodiment of the invention.
FIG. 1 is a perspective view of a catheter emplacement apparatus embodying this invention as it exists prior to usage.
FIG. 2 is an enlarged sectional view taken on the plane 2--2 of FIG. 1.
FIG. 3 is a perspective view, similar to FIG. 1, but illustrating the axial splitting of the catheter emplacement apparatus after a catheter has been inserted in a desired location in a patient's vein.
FIGS. 4-8 are schematic perspective views illustrating the successive steps involved in inserting a catheter to a desired location within a patient's vein utilizing the catheter emplacement apparatus embodying this invention.
Referring to FIGS. 1 and 2, a catheter emplacement apparatus 1 embodying this invention is shown as comprising a plastic tubular sheath 2 which has an internal diameter large enough to permit it to be inserted over a percutaneous needle, and preferably on the order of 0.1 inches to permit the ready insertion of small diameter catheters through its central bore. The external diameter of the plastic sheath 2 is preferably not in excess of 0.15 inches, in order to permit the ready insertion of the distal end of the sheath into a vein penetrated by a percutaneous needle inserted through the sheath 2 (see FIGS. 4 and 5).
The proximal end 10b of the tubular sheath 10 is rigidly bonded in the bore 20a of a plastic hub element 20, which mounts a pair of diametrically opposed, radial projections or wings 22 for convenient grasping by the fingers of the medical technician. The proximal end of the central hub aperture 20a is conically enlarged as illustrated at 20b. Longitudinal slots 21 are formed in hub element 20 which essentially divide the hub into two pieces which are joined only by thin walled conical segments 20c defining portions of the conical surface 20b and lying intermediate the two radial extensions 22 and the hub 20.
The sheath 10 is provided with a pair of diametrically opposed score lines 10a and these score lines are respectfully disposed intermediate the two radial projections 22. Additionally, the thin walled conical segment portions 20c of the hub element 20 are provided with score lines 20d that are longitudinally aligned with the sheath scores 10a. Thus, the application of opposed radial forces to the radial projections 22 results in the axial splitting of the entire catheter emplacement apparatus 1 in the manner illustrated in FIG. 3.
The utilization of the catheter emplacement apparatus embodying this invention is schematically shown in FIGS. 4-8. In FIG. 4, the catheter emplacement apparatus 1 is shown removably attached, by conventional flange 30a to a needle operating apparatus 30. The sharpened end of the needle 32 projects out of the distal end of the sheath 10 and thus penetration of the skin and the selected vein is readily achieved.
Referring to FIG. 5, the needle is then axially withdrawn from the catheter insertion apparatus 1.
In FIG. 6, there is illustrated the insertion of a conventional small diameter catheter 40 through the central aperture provided in the hub 20 and the sheath 10 so that the distal end of the catheter may be advanced along the selected vein to the desired location. Of course, the catheter insertion apparatus 1 is secured against movement by the fingers of the technician.
After insertion of the catheter to the desired location, then the step illustrated in FIG. 7 is performed. The catheter 40 is secured against movement and the catheter emplacement apparatus 1 is moved axially rearwardly so that it is disposed exterior of the patient's body.
The last step is then the manual application of opposed radial forces to the two radial projections 22 which results in the axially splitting of the catheter emplacement apparatus 1 into two pieces for removal from the catheter 40. The anchoring of the catheter 40 to the patient's body by adhesive tape is accomplished in conventional manner, as is the connection of the catheter to a suitable source of medication.
From the foregoing description, it will readily apparent that the catheter emplacement apparatus embodying this invention is of substantial benefit to the medical technician in providing the conical entrance to the small diameter bore of the tubular sheath. Moreover, the score lines 20d in the conical wall segments 20c, and the score lines 10a in sheath 10 permit the ready separation of the catheter emplacement apparatus 1 into two parts for removal from the catheter without disturbing the position of the catheter in the patient's body.
Modifications of this invention will be readily apparent to those skilled in the art and it is intended that any such modifications be defined within the scope of the appended claims.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4166469 *||Dec 13, 1977||Sep 4, 1979||Littleford Philip O||Apparatus and method for inserting an electrode|
|US4306562 *||Jul 31, 1980||Dec 22, 1981||Cook, Inc.||Tear apart cannula|
|US4345596 *||Dec 23, 1981||Aug 24, 1982||Janis Marie Young||Arterial catherization device|
|US4451256 *||Apr 28, 1982||May 29, 1984||Intermedicat Gmbh||Catheter set|
|US4581019 *||Apr 22, 1982||Apr 8, 1986||Curelaru Johan||Device for introducing a catheter-cannula into a blood vessel|
|US4772266 *||May 4, 1987||Sep 20, 1988||Catheter Technology Corp.||Catheter dilator/sheath assembly and method|
|US4865593 *||Jun 23, 1988||Sep 12, 1989||Sherwood Medical Company||Splittable cannula|
|US5098392 *||Jun 28, 1991||Mar 24, 1992||Fleischhacker John J||Locking dilator for peel away introducer sheath|
|US5125904 *||Jul 9, 1991||Jun 30, 1992||Lee Hongpyo H||Splittable hemostatic valve and sheath and the method for using the same|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US5334157 *||Sep 9, 1993||Aug 2, 1994||Gesco International, Inc.||Catheter introducer|
|US5397311 *||Sep 9, 1992||Mar 14, 1995||Menlo Care, Inc.||Bloodless splittable introducer|
|US5489273 *||Oct 7, 1994||Feb 6, 1996||Tfx Medical, Incorporated||Introducer device and methods of use thereof|
|US5536255 *||Oct 3, 1994||Jul 16, 1996||Moss; Gerald||Dilator/introducer apparatus for percutaneous gastrostomy|
|US5674241 *||Jul 15, 1996||Oct 7, 1997||Menlo Care, Inc.||Covered expanding mesh stent|
|US5680873 *||Mar 2, 1995||Oct 28, 1997||Scimed Life Systems, Inc.||Braidless guide catheter|
|US5683370||Nov 21, 1996||Nov 4, 1997||Luther Medical Products, Inc.||Hard tip over-the-needle catheter and method of manufacturing the same|
|US5741233 *||Oct 20, 1995||Apr 21, 1998||Tfx Medical, Incorporated||Introducer device and methods of use thereof|
|US5743882 *||Mar 8, 1996||Apr 28, 1998||Luther Medical Products, Inc.||Needle blunting assembly for use with intravascular introducers|
|US5752937 *||Apr 30, 1997||May 19, 1998||Medtronic Inc.||Reinforced splittable medical introducer cannula|
|US5765682 *||Jun 24, 1996||Jun 16, 1998||Menlo Care, Inc.||Restrictive package for expandable or shape memory medical devices and method of preventing premature change of same|
|US5913848||Jun 6, 1996||Jun 22, 1999||Luther Medical Products, Inc.||Hard tip over-the-needle catheter and method of manufacturing the same|
|US5916208||Nov 21, 1996||Jun 29, 1999||Luther Medical Products, Inc.||Hard tip over-the-needle catheter and method of manufacturing the same|
|US5944695 *||Sep 30, 1997||Aug 31, 1999||Becton, Dickinson And Company||Multiple sheath catheter using multiple stages and method of use|
|US5951518 *||Oct 31, 1997||Sep 14, 1999||Teleflex, Incorporated||Introducing device with flared sheath end|
|US5957893||Sep 8, 1998||Sep 28, 1999||Becton Dickinson & Co.||Hard tip over-the needle catheter and method of manufacturing the same|
|US5968070 *||Aug 11, 1997||Oct 19, 1999||Cordis Corporation||Covered expanding mesh stent|
|US6027480 *||Aug 11, 1997||Feb 22, 2000||Becton Dickinson And Company||Catheter introducer|
|US6185449||Aug 12, 1997||Feb 6, 2001||Scimed Life Systems, Inc.||Braidless guide catheter|
|US6273871 *||Dec 7, 1999||Aug 14, 2001||Becton, Dickinson And Company||Catheter introducer|
|US6336914||Jan 13, 2000||Jan 8, 2002||Gillespie, Iii Richard D.||Releasable interlock assembly having axial and rotational engagement|
|US6363273||Dec 22, 1999||Mar 26, 2002||Codman & Shurtleff, Inc.||Introducer element and method of using same|
|US6382209 *||Oct 14, 1999||May 7, 2002||Frederic J Toye||Apparatus and method enabling location of trachea breathing tube in body viscus|
|US6544247 *||Sep 7, 2000||Apr 8, 2003||Medtronic, Inc.||Introducer system|
|US6585703||Jul 26, 2000||Jul 1, 2003||Span-America Medical Systems, Inc.||Dividable introducer catheter and positive-lock needle guard combination|
|US6589212 *||Nov 8, 1999||Jul 8, 2003||Janin Group, Inc.||Guide for surgical device|
|US6635022||Dec 13, 2000||Oct 21, 2003||Scimed Life Systems, Inc.||Braidless guide catheter|
|US6808509||Apr 21, 2000||Oct 26, 2004||Scimed Life Systems, Inc.||Valved introducer sheath and related methods|
|US6887417||Nov 5, 2001||May 3, 2005||Bectondickinson And Company||Catheter sleeve assembly and one step injection molding process for making the same|
|US6994693 *||Jul 17, 2002||Feb 7, 2006||Yale University||Tunneler-needle combination for tunneled catheter placement|
|US7094218||Mar 18, 2004||Aug 22, 2006||C. R. Bard, Inc.||Valved catheter|
|US7314481||May 30, 2003||Jan 1, 2008||Wilson-Cook Medical Inc.||Stent introducer apparatus|
|US7422571||Sep 24, 2004||Sep 9, 2008||Medical Components, Inc.||Releasably locking dilator and sheath assembly|
|US7578803||Mar 8, 2005||Aug 25, 2009||C. R. Bard, Inc.||Multifunction adaptor for an open-ended catheter|
|US7731697||Feb 20, 2007||Jun 8, 2010||Incumed Llc, A Nevada Limited Liability Co.||Apparatus and method for percutaneous catheter implantation and replacement|
|US7744571||Jun 23, 2008||Jun 29, 2010||Medical Components, Inc.||Tearaway sheath assembly with hemostasis valve|
|US7811293||Feb 2, 2004||Oct 12, 2010||Philip J. Simpson||System and method for rapid placement of chest tubes|
|US7824375 *||Oct 9, 2008||Nov 2, 2010||Pacesetter, Inc.||Slittable delivery device for the delivery of a cardiac surgical device|
|US7842058||Feb 2, 2004||Nov 30, 2010||Flex Partners, Inc.||Manipulation and cutting system and method|
|US7854731||May 3, 2005||Dec 21, 2010||C. R. Bard, Inc.||Valved catheter|
|US7875019||Jun 20, 2006||Jan 25, 2011||C. R. Bard, Inc.||Connection system for multi-lumen catheter|
|US7883502||Sep 21, 2009||Feb 8, 2011||C. R. Bard, Inc.||Connector system for a proximally trimmable catheter|
|US7938806||Mar 11, 2009||May 10, 2011||Medical Components, Inc.||Tearaway introducer sheath with hemostasis valve|
|US8021340||Jan 26, 2009||Sep 20, 2011||Incumed, Llc||Enhanced apparatus for percutaneous catheter implantation and replacement|
|US8043263||Mar 25, 2009||Oct 25, 2011||Pacesetter, Inc.||Slittable delivery device assembly for the delivery of a cardiac surgical device|
|US8105287||Sep 2, 2010||Jan 31, 2012||Medical Components, Inc.||Tearaway introducer sheath with hemostasis valve|
|US8147456||Apr 5, 2010||Apr 3, 2012||Medical Components, Inc.||Hub for tearaway sheath assembly|
|US8262619||Sep 30, 2010||Sep 11, 2012||Tyco Healthcare Group Lp||Introducer sheath for catheters|
|US8273059||Jul 26, 2010||Sep 25, 2012||Medical Components, Inc.||Tearaway sheath assembly with split hemostasis valve seal|
|US8298189||Apr 5, 2010||Oct 30, 2012||Medical Components, Inc.||Hemostasis valve|
|US8348899 *||Oct 15, 2010||Jan 8, 2013||Medical Components, Inc.||Methods for inserting a catheter|
|US8382715||Jul 26, 2010||Feb 26, 2013||Medical Components, Inc.||Tearaway sheath assembly with split hemostasis valve seal|
|US8523822||Sep 17, 2008||Sep 3, 2013||Medical Components, Inc.||Tearaway sheath assembly with split hemostasis valve seal|
|US8795326||Oct 2, 2008||Aug 5, 2014||Covidien Lp||Expanding seal anchor for single incision surgery|
|US9078998||Dec 30, 2014||Jul 14, 2015||C. R. Bard, Inc.||Catheter introducer including a valve and valve actuator|
|US9101737||Mar 22, 2013||Aug 11, 2015||C. R. Bard, Inc.||Reduced friction catheter introducer and method of manufacturing and using the same|
|US9108033||Dec 29, 2009||Aug 18, 2015||C. R. Bard, Inc.||Valved sheath introducer for venous cannulation|
|US20040082913 *||Oct 22, 2003||Apr 29, 2004||Spohn Peter Dwight||Peelable PTFE sheaths and methods for manufacture of same|
|US20040098020 *||Aug 28, 2003||May 20, 2004||Medical Components, Inc.||Releasably locking dilator and sheath assembly|
|US20050049628 *||Sep 24, 2004||Mar 3, 2005||Medical Components, Inc.||Releasably locking dilator and sheath assembly|
|US20050273116 *||Feb 2, 2004||Dec 8, 2005||Simpson Philip J||System and method for rapid placement of chest tubes|
|US20110034875 *||Feb 10, 2011||Medical Components, Inc.||Methods for Inserting a Catheter|
|US20120109109 *||May 3, 2012||Asahi Intecc Co., Ltd.||Auxiliary dilator and catheter assembly having the same|
|US20130018309 *||Dec 20, 2010||Jan 17, 2013||Ewing Benjamin T||Tear-away sheath with integral stop|
|US20130226094 *||Feb 22, 2013||Aug 29, 2013||Cook Medical Technologies Llc||Introducer assembly|
|EP0652782A1 *||Apr 7, 1993||May 17, 1995||Gesco International, Inc.||Catheter emplacement apparatus|
|EP1599143A2 *||Feb 2, 2004||Nov 30, 2005||Flex Partners, Inc.||System and method for rapid placement of chest tubes|
|EP1786493A2 *||Aug 4, 2005||May 23, 2007||Arrow International, Inc.||Over-the- needle peel-away sheath catheter introducer|
|EP2335764A1 *||Nov 4, 2002||Jun 22, 2011||Becton, Dickinson and Company||Catheter sleeve assembly and one step injection molding process for making the same|
|EP2335765A1 *||Nov 4, 2002||Jun 22, 2011||Becton, Dickinson and Company||Catheter sleeve assembly and one step injection molding process for making the same|
|EP2335766A1 *||Nov 4, 2002||Jun 22, 2011||Becton, Dickinson and Company||Catheter sleeve assembly and one step injection molding process for making the same|
|EP2335767A1 *||Nov 4, 2002||Jun 22, 2011||Becton, Dickinson and Company||Catheter sleeve assembly and one step injection molding process for making the same|
|WO1996011030A1 *||Sep 29, 1995||Apr 18, 1996||Tfx Medical Inc||Introducer device and methods of use thereof|
|WO1997014456A1||Oct 18, 1996||Apr 24, 1997||Bimbo Frank||Releasably locking introducer devices|
|WO1997014468A1||Oct 18, 1996||Apr 24, 1997||Frederick Jerome W Iii||Introducer device and methods of use thereof|
|WO1999022804A1||Oct 23, 1998||May 14, 1999||Teleflex Inc||Introducing device with flared sheath end|
|WO2001008731A1 *||Jul 26, 2000||Feb 8, 2001||Vadus Inc||A dividable introducer catheter and positive-lock needle guard combination|
|WO2003039639A2 *||Nov 4, 2002||May 15, 2003||Becton Dickinson Co||Catheter sleeve assembly and one step injection molding process for making the same|
|WO2007089700A2 *||Jan 29, 2007||Aug 9, 2007||Medical Res Products B Inc||Method and subcutaneous apparatus for facilitating the replacement of an implanted catheter|
|WO2008005065A1 *||Feb 20, 2007||Jan 10, 2008||Abram D Janis||Apparatus and method for percutaneous catheter implantation and replacement|
|WO2010096893A1 *||Dec 22, 2009||Sep 2, 2010||Imris Inc.||Temperature sensing within a patient during mr imaging|
|U.S. Classification||604/161, 604/164.05|
|International Classification||A61M25/06, A61M25/08|
|Jul 30, 1992||AS||Assignment|
Owner name: GESCO INTERNATIONAL, INC., A CORP. OF TX, TEXAS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST.;ASSIGNORS:SINKO, GEORGE E.;JONES, CHARLES A.;REEL/FRAME:006229/0774
Effective date: 19920729
|Dec 9, 1996||FPAY||Fee payment|
Year of fee payment: 4
|Nov 27, 2000||FPAY||Fee payment|
Year of fee payment: 8
|Nov 17, 2004||FPAY||Fee payment|
Year of fee payment: 12